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| Name | Class |
|---|---|
| Imperial College London | OTHER |
| National Institute for Health Research, United Kingdom | OTHER_GOV |
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The goal of this randomised controlled trial is to compare the success of two types of hip replacement in patients with hip arthritis. The main question it aims to answer is whether a new type of hip replacement (called a hip resurfacing) can be as successful as an existing hip replacement (called a total hip replacement). Patients will be given either the new hip resurfacing or the existing total hip replacement and researchers will compare their function, complication rate and physical activity.
The H1 Implant is a cementless, ceramic hip resurfacing arthroplasty (HRA) device. The intended purpose of the H1 Implant is to provide an artificial substitute for a disease-damaged hip joint to replace the articulating surfaces of the hip while preserving the underlying femoral head and natural femoral neck. This is standard for a resurfacing hip prosthesis. This study will randomise patients to receive either The H1 Implant or a primary cementless ceramic-on-poly or ceramic-on-ceramic total hip replacement (THR). Composite clinical success (CCS) scores, physical activity levels and patient reported outcome measures (PROMs) will be compared for the two groups. The primary objective of the study is to determine whether the H1 Implant is non-inferior to cementless THR in terms of CCS. The key secondary objective is to determine whether the H1 Implant is superior compared to cementless THR in terms of physical activity and PROMs. Other secondary objectives are to compare the H1 Implant and THR with respect to: safety, through collection of all device-related, operative site-related and systemic adverse events; and noise generation, through patient survey.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The H1 Implant | Experimental | Cementless, ceramic-on-ceramic hip resurfacing arthroplasty (HRA) device. |
|
| Cementless total hip replacement | Active Comparator | Cementless ceramic-on-poly or ceramic-on-ceramic total hip replacement |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The H1 Implant | Device | Patients allocated to The H1 Implant arm will be implanted with the H1 Implant which is a cementless, ceramic hip resurfacing device. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite clinical success (CCS) | The primary outcome is "composite clinical success". This is a binary outcome measure. Patients are deemed to have achieved CCS if they meet all of the following criteria at the 24 month timepoint:
| 24 months post-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Physical Activity | Average daily minutes of activity and mean bouted daily moderate-vigorous physical activity (MVPA), minutes | 6 months, 12 months and 24 months post-operatively |
| Physical Activity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Camilla Halewood, PhD | Contact | +442075943600 | camilla.halewood@embody-ortho.com | |
| Mariam Al-Laith, PhD | Contact | +442075943600 | m.al-laith@imperial.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Justin Cobb, Prof | Imperial College London | Principal Investigator |
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| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| D001168 | Arthritis |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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Randomisation will be performed using variable block randomisation with block sizes of 4, 6 and 8, with a 1:1 allocation to the 2 groups, with stratification across sites. This will ensure approximately equal numbers across groups and approximately the same number per group at each site (to control for differences in the trial population because of environmental, social and demographic factors), while allowing different total numbers at each site. It will also ensure that at any given time, the numbers in each group will be approximately equal, allowing the interim analyses to take place. The randomisation will be managed by the contract research organisation (CRO) via an electronic data capture (EDC) system, which uses a validated randomisation algorithm. Once a patient has been consented, they will be assigned to a treatment group according to the pre-determined order inside the block. Stratification by site is recommended for multi-centre studies.
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The patients, clinical assessors and data analysts will be blinded to the intervention each patient has received for the 24 month post-operative period. The surgeon, operating theatre team, radiographic analysts and CRO cannot be blinded but will not be involved in the care of the patient after the intervention unless the patient requires revision surgery.
| Cementless total hip replacement | Device | Patients allocated to cementless total hip replacement arm will be implanted with a cementless ceramic-on-poly or ceramic-on-ceramic total hip replacement |
|
Physical performance assessment: number of chair stands in 30 seconds and time taken to perform stair climb test
| Pre-operatively, 6 months, 12 months and 24 months post-operatively |
| Physical Activity | Hip Outcome Score (HOS) Questionnaire | Pre-operatively, 6 months, 12 months and 24 months post-operatively |
| Physical Activity | UCLA (University of California Los Angeles) Activity Score | Pre-operatively, 6 months, 12 months and 24 months post-operatively |
| Noise | Noise questionnaire | 6 weeks, 6 months, 12 months and 24 months post-operatively |